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Extraction & Isolation Engineering: Advanced process development for the precision isolation of both small and large molecules from botanical matrices, optimized for yield, purity, and scalability.
Specialized Chromatographic Development: Engineering of sophisticated HPLC and LC-MS methodologies specifically tailored to resolve the complex chemical profiles of botanical APIs and finished drug products.
Regulatory Analytical Testing: Comprehensive testing protocols designed to validate botanical API quality, ensuring strict adherence to FDA "Totality of Evidence" standards and pharmacopeial compliance.
Pharmaceutical Certification: Generation of rigorous Certificates of Analysis (CoA) for botanical drug substances and products, documenting every critical quality attribute (CQA) required for IND/NDA dossiers.
ICH-Compliant Stability Programs: Execution of stability-indicating studies in accordance with ICH Q1A-Q1E guidelines to ensure the chemical and biological integrity of botanical formulations over their intended shelf life.
Botanical Profiling
High-Resolution HPLC Profiling: specialized High-Performance Liquid Chromatography (HPLC) is used to detect, resolve, and quantify low-abundance metabolites that are often masked in standard full-spectrum chromatograms.
Deconvolution of Complexity: By leveraging our extensive database of historical retention times and spectral data, we have higher success rates in structurally elucidating and identifying "unknown" peaks within your botanical product.
Regulatory Compliance: Transforming "unidentified peaks" into "characterized markers" is a critical step in satisfying Module 3 (Quality) requirements for FDA Botanical IND applications, demonstrating full control over the chemical composition of your drugg.
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